Medication Counselling on Unlicensed Medicines Should Be Improved – Results from a Finnish Survey for Patients and Pharmacy Staff

Tiina Liipo,1,2 Tuire Prami,2 Ilona Iso-Mustajärvi,2 Mari Pölkki,2 Anne Juppo1 1University of Helsinki, Faculty of Pharmacy, Division of Pharmaceutical Chemistry and Technology, Helsinki, Finland; 2Oriola, Espoo, FinlandCorrespondence: Anne Juppo, University of Helsinki, Faculty of Pharmacy, Division of Pharmaceutical Chemistry and Technology, Viikinkaari 5 E, 00014 University of Helsinki, Helsinki, Finland, Tel +358505306147, Email [email protected]: Finnish authorities have published specific instructions for prescribing, handling, and dispensing unlicensed medicines and for the associated communication with patients. However, there is a clear research gap concerning the quality of medication counselling given by doctors and especially pharmacists to patients who are prescribed unlicensed medicines. The success of such counselling was studied with a survey for both pharmacy staff and patients.Methods: The survey was conducted in 2022 with two electronic semi-structured questionnaires, one for patients (or caregivers of underaged patients) purchasing medicines with special or fixed-term special permits from community pharmacies in Finland and one for the pharmacy staff dispensing such medication.Results: In all, 49% of the 389 pharmacists did not know if the prescribing doctor had given any counselling to the patient, and 52% of the pharmacists had not given any counselling to the patient themselves. Still, 51% of the pharmacists considered that the patient had received sufficient medication counselling. Almost every one of the 36 patients expressed that they had received medication counselling, 61% of them from the prescribing doctor and 53% from a pharmacist.Conclusion: Medication counselling on unlicensed medicines should be improved to ensure their safe and effective use. This survey revealed that many patients did not receive any such medication counselling as required by the Finnish Medicines Decree.Plain Language Summary: If patients need medicines that are not available in their own country, they can be treated with unlicensed medicines imported from abroad.Community pharmacies deliver tens of thousands of packages of unlicensed medicines yearly in Finland, and we wanted to find out whether patients receive appropriate information about their use.We contacted pharmacy staff and patients using unlicensed medicines and conducted an electronic survey to ask about their experiences on whether patients receive sufficient information on these medicines.Almost every patient participating the survey felt that they had received counselling on their unlicensed medication, more often from a doctor than a pharmacist, despite most of the pharmacist responding to this survey had a lot of work experience and dispensed these medicines regularly.Patients have the right to receive supporting information to ensure the effectiveness and safety of their medication, and pharmacists have a crucial role in ensuring this.Based on this study, we suggest that pharmaceutical companies and authorities should provide reliable supporting material on the use of unlicensed medicines for doctors, pharmacists, and patients, bearing in mind the respective information needs of these groups.Keywords: unlicensed medicines, medicines with special permit, medication counselling, survey